RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:

Overall survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biochemical failure according to the Phoenix (nadir + 2) definition [ Time Frame: From the date of randomization to the date of first documented rise in PSA of 2 ng/ml above the post treatment nadir value. ] [ Designated as safety issue: No ]

Local recurrence [ Time Frame: From the date of randomization to the date of first palpable progression or pathologic confirmation of local progression or to the date of first biochemical failure (nadir +2ng/ml) once the possibility of distant metastasis is ruled out. ] [ Designated as safety issue: No ]

Regional recurrence [ Time Frame: From the date of randomization to the date of first documented progression in pelvic lymph nodes or the date of first documented biochemical failure (BCF) if the CT of the pelvis was prompted by a BCF. ] [ Designated as safety issue: No ]

Distant metastasis [ Time Frame: From the date of randomization to the date of first documented metastatic disease by any measure or to the date of first documented biochemical failure if diagnostic imaging is prompted by BCF. ] [ Designated as safety issue: No ]

Prostate cancer-specific mortality [ Time Frame: From the date of randomization to the date of death due to prostate cancer/complication of treatment. ] [ Designated as safety issue: No ]

Non-prostate cancer-specific mortality [ Time Frame: From the date of randomization to the date of death without the evidence of prostate cancer/complication of treatment. ] [ Designated as safety issue: No ]

Rate of salvage androgen-deprivation therapy [ Time Frame: From the end of treatment to the date of first administration of ADT. ] [ Designated as safety issue: No ]

Rates of OS for patients treated with the 3 different radiotherapy modalities in each arm [ Time Frame: From the date of randomization to the date of death due to any cause. ] [ Designated as safety issue: No ]

Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0 [ Time Frame: From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT. ] [ Designated as safety issue: Yes ]

Time to "late" grade 3+ adverse events as assessed by NCI CTCAE v. 4.0 [ Time Frame: From the date of completion of RT to the date of first grade 3 or above adverse event occurring 30 days after the completion of RT. ] [ Designated as safety issue: Yes ]

Freedom from Failure [ Time Frame: From date of randomization to the date of first event of biochemical failure or local recurrence or regional reccurrence or distant metastasis. ] [ Designated as safety issue: No ]

Comparison of prostate cancer-specific health related quality of life (HRQOL) change as measured by EPIC [ Time Frame: From date of randomization to the following times: last week of RT, 6 months, 1 year and 5 years post RT. ] [ Designated as safety issue: No ]

Comparison of fatigue status as measured by the Patient Reported Outcome Measurement Information System (PROMIS) fatigue domain [ Time Frame: From date of randomization to the following times: last week of RT, 6 months, 1 year and 5 years post RT. ] [ Designated as safety issue: No ]

Assessment and comparison of Quality Adjusted Life Years (QALYs) [ Time Frame: From date of randomization to the following times: last week of RT, 6 months, 1 year and 5 years post RT. ] [ Designated as safety issue: No ]

Correlation between the fatigue PROMIS score change and plasma cytokine change [ Time Frame: From date of randomization to 3 weeks from start of RT. ] [ Designated as safety issue: No ]

Compare acute and late treatment adverse events of these regimens and correlate these events with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 assessment.

Arm I: Patients undergo EBRT* once daily on days 1-5 for about 9 weeks (44 treatments). Some patients instead receive EBRT with high-dose rate or low-dose rate brachytherapy implant on days 1-5 for about 5 weeks (25 treatments). NOTE: *Type of RT is at discretion of treating physician and may include either 3D-conformal RT or intensity-modulated RT.

After completion of study therapy, patients are followed up periodically.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate diagnosed within the past 180 days and at intermediate-risk for recurrence by meeting 1 or more of the following criteria:

Gleason score = 7

Prostate Specific Antigen (PSA) > 10 and ≤ 20 ng/mL

Baseline serum PSA value performed within 60 days with an FDA-approved assay (e.g., Abbott, Hybritech)

Baseline PSA must not be obtained during any of the following time frames:10-day period after prostate biopsy, after initiation of androgen-deprivation therapy, or within the past 30 days after discontinuation of finasteride (90 days for dutasteride)

Clinical stage T2b or T2c disease

Patients previously diagnosed with low-risk (Gleason score < 6, clinical stage < T2a, and PSA < 10 ng/mL) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate-risk disease according to the protocol criteria are eligible for enrollment within 6 months of the repeat biopsy procedure

If findings of extracapsular extension or seminal vesicle invasion are noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol

Primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement

No patients with all 3 intermediate-risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer

The percentage of biopsy cores involved will only be considered with respect to eligibility for those patients with all 3 of the above risk factors (i.e., patients with one or two of the above risk factors are eligible irrespective of the percentage of biopsy cores involved)

Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT scan or MRI), nodal sampling, or dissection within the past 60 days (required for patients with 2-3 risk factors)

Abdominal imaging not required for a single intermediate-risk factor (these studies may be obtained at the discretion of the treating physician)

Lymph nodes that are equivocal or questionable by imaging allowed without biopsy if nodes ≤ 1.5 cm

Any node > 1.5 cm on imaging requires a negative biopsy

No evidence of bone metastases on bone scan within the past 60 days

Bone scan not required for patients with a single intermediate-risk factor (scan may be obtained at the discretion of the treating physician)

No prior radiotherapy (RT), including brachytherapy, to the region of the study cancer that would result in overlap of RT fields

Patients undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) score ≤ 15 within the past 60 days of registration, and no history of prior transurethral resection of the prostate (TURP)

TURP allowed for patients who receive external-beam radiation therapy only

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936390